1. Field of the Invention
The present invention relates to flour-based food products capable to reduce body weight and plasma lipids, LDL cholesterol and glucose.
2. Description of the Related Art
Overweight is usually linked to an increase in total body weight with obesity being its extreme manifestation. It is a social problem whose prevalence in industrialized nations is on the increase and which predisposes to pathologies such as diabetes mellitus, hypertension, cardiopathy, gall bladder diseases and a few neoplastic forms. The National Health and Nutrition Exam Survey In has estimated that, in industrialized nations, 59.4% of men and 49.9% of women are overweight and 19.9% of men and 25.1% of women are obese [National Cholesterol Education Program, Third Report NIH Publication No. 01-3760 May 2001].
The term “obesity” is frequently erroneously used as a synonym for “overweight”. Accurate and expensive methods exist for measuring total body weight such as dual-energy X-ray densitometry, nuclear magnetic resonance, computerized axial tomography, but the most used method, characterised by accuracy and reliability, is the measurement of weight and height. The most widely used formula for relating height to weight is the body mass index (BMI) given by the weight/height ratio in which weight is expressed in kilograms and height in metres. A BMI between. 18.5 and 24.9 kg/m2 is considered normal for most people. A person of 70 kg weight and 1.70 m height has a BMI of 70/1.702=24.2 kg/m2. Overweight is defined as a BMI of between 25 and 29.9 kg/m2. Obesity is divided into three classes: class I with a BMI of between 30 and 34.9 kg/m2, class II with a BMI of between 35 and 39 kg/m2 and class III with a BMI>40 kg/m2.
Body fat and its distribution are affected by the amount of calories (energy) ingested, gender, age, level of physical activity, chronic use of a number of drugs and various pathologies. The dietary component is certainly the main cause of increased BMI. If, through the diet, energy needs are continuously exceeded due to incorrect dietary habits, an increased BMI is unavoidable, although the extent of increase depends on the individual. In both sexes body fat increases with age and, after puberty, women have a greater amount of adipose tissue at the same age. Energy needs are linked to activity, therefore sedentariness can be considered as another basic factor in causing overweight.
Although these two mentioned factors, namely caloric intake and sedentariness, are undoubtedly the main causes responsible for this problem, in many individuals a strong influence of genetic factors has been observed, which can increase the predisposition to the problem development until the establishment of obesity. Five syndromes with early childhood onset are described (Prader Willi, Ahlstrom, Laurence-Moon-Biedl, Cohen and Carpenter syndromes), wherein a genetic contribution is critical to the onset of obesity [Harrison, Principals of Internal Medicine. 14° edition. Vol. 1: 525-534; L M Tierney, S J McPhee, M A Papadakis. Current Medical Diagnosis & Treatment 2004, p.1215-1217].
Less than 1% of obese patients have endocrine pathologies responsible for obesity, such as Cushing's disease, polycystic ovary syndrome, hypothyroidism, post-trauma or iatrogenic hypothalamic damage and destructive lesions in the ventromedial and paraventricular nuclei, or take drugs which promote obesity (e.g. phenothiazine, anti-depressants, anti-epileptics and anti-hypertensives).
Weight gain can lead to an increase in health risks even if the BMI does not exceed 25 kg/m2; in women a weight gain of over 5 kg is associated with an increased risk of diabetes and cardiopathy and in men any weight gain after the age of 25 involves a health risk (W C Willet, W H Dietz, G A Colditz. Primary care: guidelines for healthy weight. NEJM 1999; 341: 427-434).
Deposition of fat in the upper body is associated with greater health risks compared to deposition of fat in lower regions. The risks associated with overweight are: diseases of the cardiovascular system (increased workload, atherosclerosis, increased risk of sudden death and increased prevalence of hypertension), diabetes mellitus (type 2 diabetes mellitus is practically non-existent in subjects with a BMI<22 kg/m2), neoplasias (tumours, whose incidence has been observed to increase in obese patients are mammary and endometrial carcinoma in post-menopausal women, prostate carcinoma in men and colorectal cancer in both sexes), gall bladder diseases (calculosis of the gall bladder is related to increased cholesterol production in obese patients), alteration of pulmonary function (increased sleep apnoea risk), joint and skin disorders (osteoarthritis, gout, acanthosis nigricans, increased skin turgidity and fragility and susceptibility to mycosis), pathologies of the endocrine system (insulin resistance, early menarche, irregular and anovular cycles, early menopause).
The most effective therapeutic programme consists of a multidisciplinary approach with a low calorie diet, behaviour modifications, aerobic physical exercise and psychological support.
In industrialized nations, cardiovascular diseases are the cause of about 30% of deaths. Over 85% of the latter occur in the over 65 aged population with the remaining 15% occurring at an earlier age, often following the first episode (in 80% of cases). These epidemiological factors indicate that, in order to face the problem in an effective manner, it is essential the possibility to identify the risk factors.
The major risk factors have been identified and are as follows:
An increase in LDL cholesterol (LDL-C); a reduction in HDL cholesterol (HDL-C); cigarette smoke; hypertension; type 2 diabetes; obesity; premature death of a first degree relative (man<55 years; woman<65 years).
The control of modifiable risk factors therefore becomes essential for accurate prevention. Observational studies have shown that such modifiable factors are responsible for about 85% of total risk and their removal would hence result in a substantial disease reduction.
Cholesterol is particularly important as a risk factor, in that lowering levels to less than 160 mg/dL is established as being sufficient to substantially cut down cardiovascular mortality even in the presence of other risk factors.
On the other hand all elements leading to high cholesterol levels are to be considered as risk factors. One of these is dietary saturated fatty acids (animal fats) which increase blood cholesterol and therefore their intake should be limited.
In general, the recommendations (NCEPT: National Cholesterol Education Program) entail reducing lipid intake to averagely less than 30% of total daily calories and, among these lipids, only less than a third (hence, less than 10% of total daily calories) should be saturated (i.e. of animal origin). Another alternative method of facing the problem is to keep lipid levels under control by adjusting them naturally (with food or fibre) so as to achieve levels with reduced risk as given in Table 1 (Goodman & Gilman. The pharmacological basis of therapeutics: eleventh edition: 933-945.)
TABLE 1Classification of plasma lipid levels according to NCEPT guidelinesTotal cholesterol<200 mg/dLDesirable200-239 mg/dLModerately raised≧240 mg/dLHighHDL-C<40 mg/dL man; <50 mg/dL womanLow>60 mg/dLHighLDL-C (LDL cholesterol)<129 mg/dLOptimal/good130-189 mg/dLHigh>190Very highTriglycerides<150 mg/dLNormal150-199 mg/dLNormal/high200-499 mg/dLHigh≧500 mg/dLVery high
The evaluation of plasma lipid levels shall be carried out after at least 12 hours of fasting. LDL-C measurement is calculated using the formula:LDL-C=(total cholesterol−(triglycerides: 5)−HDL-C).
The first therapy target should be connected to healthy eating recommendations and to activity (lifestyle changes). If such provisions do not result in the desired effects, an actual therapy should be initiated.
The following Table 2 proposes the suggestions adopted by NCEPT.
TABLE 2LDL-C levels at which to take measures by changing lifestyleor by undergoing therapyLDL-C levelsLifestyle changesPatient without coronary heart disease>160with 0 or 1 risk factorPatient without coronary heart disease>130with 2 risk factorsPatient with coronary heart disease or equivalent>100cardiovascular disorder*TherapyPatient without coronary heart disease≧190with 0 or 1 risk factorPatient without coronary heart disease and 2 or more risk≧160factors and a 10-year risk of <10%Patient without coronary heart disease and 2 or more risk≧130factors and a 10-year risk between 10 and 20%Patient with coronary heart disease or equivalent ≧100**cardiovascular disorder**equivalent cardiovascular disorder = peripheral arteriopathy, abdominal aortic aneurysm, symptomatic carotid stenosis, 10-year risk >20% (“10-year risk” means the risk of having coronary heart disease within 10 years; it is calculated as a percentage).**some authors consider starting therapy only when the LDL-C level is ≧130 mg/dL.
The summation of points relating to various risk factors represents the percentage of patients that, further to thorough epidemiological studies, have had a coronary episode (ischemic-infarct) within 10 years following their assessment [National Cholesterol Education Program. Third Report NIH Publication No 01-3760 May 2001].
The essential point for a therapeutic/corrective intervention on overweight, other than cholesterol and triglyceride levels, is the diet: the main object is a reduction in fat intake (a reasonable diet is one with less than 25% of calories deriving from fats) and the introduction of fibres. It has been found to be very useful the exclusion of alcoholic drinks and foods having high calorie content but few nutrients, and the increase of the meal frequency, while reducing amount concerned and increasing the complex carbohydrate and fibre content thereof.
In the daily life, there are situations where the fat intake can be difficult to control, mainly because fats increase food palatability. Therefore, a drastic reduction in fat content, cholesterol included, can be found not to have an appreciable gastronomic value. This limitation results in a tendency to go on a diet for limited periods of time, thus running the known risk of quickly regaining the weight at the end of such periods (yo-yo effect).
Therefore, the research attempts have turned towards the introduction of fibres or phytosterols in frequently consumed foods, such as pasta and bread, in order to limit the fat and cholesterol absorption. In this way, while still continuing to eat the same types of foods, fat absorption is reduced with consequent reduction of plasma lipid levels (cholesterol and triglycerides) and body weight.
It is therefore an object of the present invention to provide foods that can be frequently consumed, while being at the same time capable of limiting the fat absorption in order to comply with a balanced and healthful diet requirements.